WRITTEN QUESTION No. 1542/97 by Hiltrud BREYER to the Commission. Phosphate ester poisoning due to the use of Tiguvon (Fenthion) manufactured by Bayer Leverkusen
Date: 1997-05-05
Institutions: BREYER, European Parliament
Subjects: analytical chemistry, consumer information, consumer protection, dangerous substance, domestic animal, insecticide, labelling, market approval, public health, veterinary medicinal product

C 45/48

EN

Official Journal of the European Communities

10. 2. 98

(98/C 45/58)

WRITTEN QUESTION E-1542/97

by Hiltrud Breyer (V) to the Commission

(5 May 1997)

Subject: Phosphate ester poisoning due to the use of Tiguvon (Fenthion) manufactured by Bayer Leverkusen

The  flea-repellant  Tiguvon  (Fenthion)  manufactured  by  Bayer  Leverkusen  can  be  administered  in  different
forms. Tiguvon 10 is intended for cats over 2 kg in weight. The use of Tiguvon 20 is recommended for dogs
weighing between 3 and 10 kg, while dogs with a body weight of more than 10 kg should be treated with Tiguvon
20 G. People who have repeatedly treated their pets with Tiguvon (Fenthion) have suffered serious phosphate
ester poisoning. As it was unable to answer my Question E-1470/96 (1) on the same subject, I would ask the
Commission to answer the following question as a matter of urgency:

In the Commission(cid:146)s opinion, does Tiguvon comply with the EU authorizing directives?

(1)  OJ C 345, 15.11.1996, p. 76.

Answer given by Mr Bangemann on behalf of the Commission

(27 June 1997)

Tiguvon (Fenthion) is a veterinary medicinal product. It has been authorised by the Member States according to
the provisions of Council Directive 81/851/EEC on the approximation of the laws of the Member States relating
to  veterinary  medicinal  products (1)  and  Council  Directive  81/852/EEC  on  the  approximation  of  the  laws  of
Member States relating to analytical, pharmatoxicological and clinical standards and protocols in respect of the
testing  of  veterinary  medicinal  products.  These  directives  lay  down  the  procedure  to  authorise  a  veterinary
medicinal product under the decentralised procedure.

In order to obtain a marketing authorisation according to the above mentioned directives an applicant has to
produce  the  results  of  all  physico-chemical,  biological,  microbiological,  toxicological,  pharmacological  and
clinical tests carried out on the product. Detailed studies on toxicology have to refer to potential risks from the
exposure of human beings to the veterinary medical product as a result of the administration to the animal. All
information which is relevant to the evaluation of the veterinary medicinal product has to be included in the
dossier for the application for marketing authorisation, whether favourable or unfavourable to the product. In
particular, all relevant detail must be given of any incomplete or abandoned test or trial relating to the product.
Moreover,  after  marketing  authorisation,  any  information  not  in  the  original  application,  pertinent  to  the
assessment of benefit and risk, shall be submitted forthwith to the authorities.

As a result of its evaluation of the relevant documentation the national authority will only grant a marketing
authorisation,  if  it  is  assured  that  instructions  for  correct  usage  and  a  warning  are  included  in  all  packets  of
products which present a potential risk through administration to the animal. In the case of Tiguvon the (human)
user is advised to avoid close contact and not to touch the animal at the application site.

(1)  OJ L 317, 6.11.1981, as amended by Council Directives 90/676/EEC OJ L 373, 31.12.1990, and 93/40/EEC OJ L 214, 24.8.1993.

(98/C 45/59)

WRITTEN QUESTION E-1549/97

by Niels Kofoed (ELDR) to the Commission

(5 May 1997)

Subject: Public services and procurement in Objective 5B areas

Will the Commission consider investigating the possibility of changing the contract directives in force in such a
way that services › e.g. transport › and goods can be procured without further weakening provincial areas and